Research of Biomarkers in Duchenne Muscular Dystrophy Patients | DuchenneXchange

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Research of Biomarkers in Duchenne Muscular Dystrophy Patients

The purpose of this study is to identify potential biomarkers for the diagnosis, disease progression assessment and response to treatment in patients with Duchenne Muscular Dystrophy.

mechanism of action:
No pharmaceutical intervention

results:
https://clinicaltrials.gov/ct2/show/results/NCT01380964

study details

start date: June 2011

estimated completion: December 2015

size / enrollment: 220

primary outcomes:

IBiSD aims to identify and validate new and disease-specific biomarkers. [ Time Frame: End of study ]
This study will establish the relevance of urinary and blood biomarkers for the diagnosis, follow-up and assessment of treatment response in patients with DMD (IBiSD1, 2 and 4). IBiSD will also attempt to establish the seroprevalence to the different strains of AAV in patients with DMD (IBiSD3).

exclusion criteria:
FOR PATIENTS:
• Concomitant chronic or acute muscular, endocrine, infectious, allergic or inflammatory disorder in the three weeks preceding the blood test
• Intake of medicines other than angiotensin-converting enzyme inhibitors, beta blockers, dietary supplements, vitamins, alendronate and methylphenidate. Steroids (and medicines prescribed with them such as calcium supplements and proton pump inhibitors) will be discussed
• Mental retardation or autism
• Vaccination or treatment with immunoglobulins within the three months preceding inclusion
FOR CONTROLS:
• Concomitant chronic or acute muscular, neurological (including mental retardation and autism), infectious or inflammatory disorder in the three weeks preceding the blood test
• Vaccination or treatment with immunoglobulins within the three months preceding inclusion